Chronic hepatitis C virus (genotype 1b) infection MedDRA version: 12.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C MedDRA version: 12.1 Level: LLT Classification code 10019744 Term: Hepatitis C MedDRA version: 12.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus MedDRA version: 12.1 Level: LLT Classification code 10047457 Term: Viral hepatitis C
Conditions
Interventions
Product Name: AZD7295
Product Code: AZD7295
Pharmaceutical Form: Capsule*
CAS Number: 929890-64-2
Current Sponsor code: AZD7295
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Arrow Therapeutics Ltd. (a member of the AstraZeneca group of companies)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has confirmed chronic HCV (genotype 1b) infection (diagnosis at least six months before screening), with no signs of decompensated liver cirrhosis (Child-Pugh A is acceptable). 2. The patient’s plasma HCV RNA load is above 100,000 IU/mL. 3. The patient (male or female) is aged 18–65 years (inclusive). 4. The patient's BMI is in the range 18–34 kg/m2 (inclusive). 5. The patient shows no clinically significant abnormalities in ECG. 6. The patient is HCV treatment-naïve (this includes investigational HCV treatments). 7. The patient is HIV- and HBV-negative. 8. Female patients of child-bearing potential must agree to use at least 2 methods of contraception if they are not abstinent, one being a condom, for the duration of the study and for four months following the last RBV dose. In addition, during treatment with AZD7295, if females are using the oral contraceptive pill they must have been taking the same oral contraceptive for 3 months before screening and throughout the study. 9. Male patients must agree that they and their female partners (if of child bearing potential) will use at least 2 methods of contraception (one being a condom) for the duration of the study and for 7 months following the last RBV dose (unless the patient is abstinent). 10. The patients thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels show adequately controlled thyroid function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has received any investigational drug within the three months (90 days) preceding Day 1 of the study. 2. The patient has decompensated liver disease or portal hypertension (patients with Child-Pugh A cirrhosis are acceptable). 3. The patient shows any evidence of hepatocellular carcinoma or has a serum alpha-fetoprotein level of >500 ng/mL. 4. The patient has had any surgery of the gastro-intestinal tract that is likely to affect drug absorption. [Note: Patients with cholecystectomy are acceptable and are not excluded by this criterion.] 5. In the opinion of the patient’s general practitioner or hepatologist or the Investigator, the patient should not participate in the study. 6. The patient has a history of chronic retinopathy or shows other evidence of chronic retinopathy on physical examination (history or fundoscopic evidence of retinal haemorrhage, retinal artery obstruction or retinal vein obstruction). 7. The patient has diabetes mellitus (type I or II). [Note: Patients on stable oral medication with adequately controlled blood sugar levels are acceptable and are not excluded by this criterion.] 8. The patient shows any evidence of chronic cardiac or pulmonary disease associated with ongoing functional limitation (e.g. NYHA grade > 1). 9. The patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids (e.g. severe asthma, severe arthritis or autoimmune conditions, organ transplantation, adrenal insufficiency, etc.). 10. The patient has one or more additional known primary or secondary causes of liver disease other than hepatitis C (e.g. alcoholism, malignancy with hepatic involvement, haemochromatosis, alpha 1 antitrypsin deficiency, Wilson’s disease, other congenital or metabolic conditions affecting the liver, severe cardiopulmonary disease, etc.). [Note: Gilbert’s syndrome and Dubin-Johnson syndrome (two benign disorders associated with low grade hyperbilirubinaemia, to be confirmed by laboratory tests) and Child–Pugh A cirrhosis will not exclude patients from participation in this trial.] 11. The patient has any other concurrent medical condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study (e.g. concurrent malignancies, alcoholism, history of unstable angina, repeated myocardial infarction or congestive heart failure, haemoglobinopathies, active rheumatoid arthritis requiring chronic drug treatment, renal insufficiency, or other significant hormonal conditions, active tuberculosis under current treatment, etc.). [Note: Controlled haemophilia or hypertension are acceptable.] 12. The patient has a history of severe psychiatric illness, including severe depression, history of suicide attempt or suicidal ideation, or psychosis requiring medication or psychotherapy. [Note: Patients with anxiety on stable medications are acceptable.] 13. The patient has a history of a severe seizure disorder or current anticonvulsant use for control of seizures. 14. The patient has any concurrent medical condition or laboratory abnormality that would constitute a contraindication for the use of pegylated interferon. 15. The patient has any concurrent medical condition or laboratory abnormality that would constitute a contraindication for the use of ribavirin. 16.The patient is currently using, and is unable to discontinue the use of any herbal medication or pharmaceutical agent that
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the Rapid Virologic Response (RVR) of multiple oral doses of AZD7295 in conjunction with standard of care (SoC) in patients with chronic hepatitis C virus genotype 1b infection.;Secondary Objective: 1. To determine the viral load reduction of multiple oral doses of AZD7295 in conjunction with SoC in patients with chronic hepatitis C virus genotype 1b infection. 2. To determine the safety and tolerability of multiple oral doses of AZD7295 in conjunction with SoC in patients with chronic hepatitis C virus genotype 1b infection. 3. To determine the pharmacokinetics of multiple oral doses of AZD7295, PEG and RBV in patients with chronic hepatitis C virus genotype 1b infection. ;Primary end point(s): To determine the Rapid Virologic Response (RVR) of multiple oral doses of AZD7295 in conjunction with standard of care (SoC) in patients with chronic hepatitis C virus genotype 1b infection. | — |
Countries
Hungary, Slovakia
Outcome results
None listed